Significant regulatory changes are here, and proactive compliance has never been more critical. The European Commission has introduced four new hazard classes under the CLP Regulation through Delegated Regulation (EU) 2023/707, which are now in force. These classifications address hazards that go beyond the traditional scope of the Globally Harmonized System (GHS).
New Hazard Classes
The revised CLP Regulation introduces new hazard classes to better capture serious human health and environmental risks.
Endocrine Disruptors (ED)
For both human health (ED HH) and the environment (ED ENV). These substances interfere with hormone systems, potentially leading to reproductive, developmental, or ecological effects.
Persistent, Bioaccumulative and Toxic (PBT) and Very Persistent and Very Bioaccumulative (vPvB)
These substances remain in the environment, accumulate in living organisms, and can cause long-term adverse effects.
Persistent, Mobile and Toxic (PMT) and Very Persistent and Very Mobile (vPvM)
These chemicals have high mobility in the environment, increasing the likelihood of groundwater contamination and widespread exposure.
Compliance Deadlines
Companies placing substances or mixtures on the EU market should be aware of the following compliance timelines:
Substances
- Placed on the market after May 1, 2025: Must comply with the new hazard classifications at the time of market entry.
- Placed on the market before May 1, 2025: Must comply by November 1, 2026.
Mixtures
- Placed on the market after May 1, 2026: Must comply with the new hazard classifications immediately.
- Placed on the market before May 1, 2026: Must comply by May 1, 2028.
How Trinity Consultants Life Sciences Can Help
Navigating these complex updates takes more than a checklist. It takes expertise. Our team is ready to help you assess, plan, and implement a strategy that protects your business and the communities you serve.
Expert Toxicology Team
Our toxicology and regulatory staff are experts in navigating the new hazard classes, with advanced skills in:
- Interpreting ECHA guidance and OECD test methods
- Evaluating endocrine disruption potential
- Assessing bioaccumulative and persistent chemical behavior
- Delivering justified and traceable classifications
Expert SDS & Regulatory Compliance Team
Our SDS professionals support you with:
- Strategic planning for SDS and label updates
- Identifying affected products and prioritizing updates
- Integrating new hazard classes into CLP-compliant documentation
- Ensuring defensibility of classifications during inspections and audits
Position Your Business for Success
- Mitigate compliance risks and stay ahead of the regulations by meeting EU requirements before the compliance deadline
- Minimize disruption and reduce the impact on your supply chain and daily operations
- Enhance corporate credibility and build trust by demonstrating to your customers, partners, and investors that you prioritize health, safety, and transparency
- Stay competitive and position your business as a regulatory leader in your industry
At Trinity Consultants Life Sciences, we help you stay ahead of the curve, not just keep up. Contact us today to schedule a compliance review or to learn more about how these changes may affect your portfolio. Please contact Amanda Tuesdale or visit TrinityConsultants.com to learn more.
